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ASEAN Effort Progressing on CMC/GMP Harmonization, But Differences Remain

Dec 20th, 2010

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An analysis of the CMC/GMP regulatory framework among the Association of South East Asian Nations (ASEAN) shows significant progress in moving toward a more cohesive and harmonized approach, although differences remain in individual country requirements and procedures.

ASEAN implemented a common technical document (“ACTD”), similar to the ICH CTD, in 2009, and is developing a common set of core CMC guidelines applicable across the member countries.

A mutual recognition agreement (MRA) on GMPs signed by all the ASEAN countries in 2009, which provides for the sharing of inspection and registration information, represents another recent step forward in the cooperation effort.  The MRA becomes effective at the beginning of 2011. Increased interaction with the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is also helping drive GMP alignment on an internal and inter-regional level.

The harmonization of pharmaceutical regulation is an important component in the association’s primary objective of facilitating elimination of technical barriers to free trade while strengthening regulatory oversight.

The 10 member countries include six that are more dominant players in the pharmaceutical arena – Thailand, Singapore, Indonesia, Malaysia, Vietnam and the Philippines – and four others – Myanmar, Cambodia, Brunei and Laos.  The combined population is over 500 million.

ISPE’s Asia Pacific Focus Group Shares Insights

The progress made in achieving harmonization in the ASEAN region and some of the remaining gaps and challenges for

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global pharmaceutical firms in interacting with the individual countries and meeting application and GMP requirements were addressed at a session of the ISPE annual meeting in Orlando, Florida in early November.

The session focused on new and emerging regulations and guidelines and provided a forum for ISPE’s Asia Pacific Focus Group to share its knowledge of CMC and GMP experiences in these countries.

In introducing the session, Pfizer Global Regulatory CMC Executive Director Chi-wan Chen explained that the focus group was formed in mid-2009 to bring together regulatory CMC/GMP professionals from various companies that have responsibilities in either portfolio filing and/or regulatory policy in the Asia-Pacific area to create a networking/experience-sharing forum.  The Orlando session was the focus group’s first opportunity to share its discussions in a public forum.

At the session, Eli Lilly Principle Consultant for Regulatory Affairs Susan Stolz and GlaxoSmithKline (GSK) CMC Advocacy and Regulatory Intelligence Director Bekki Komas provided the focus group’s insights into current efforts taking place in the ASEAN region.

Chen – a former key drug CMC review official – followed with an analysis of the current situation in China and how its regulatory processes are evolving toward a more Western model (IPQ “In the News” November 29).

Other forum members addressing CMC/GMP developments across the Asia/Pacific region at the session were Lilly CMC Global Regulatory Affairs Director Jeffrey Ferguson (on Korea), Merck Associate Director Pramod Kotwal (on Japan), and Bristol-Myers Squibb Executive Director Mark Rosolowsky (on Taiwan and India).

[The analysis of the progress and challenges in the ASEAN region, with insights provided by Stolz and Komas at the ISPE session, continues on page 2.  The seven-page story is available to non-subscribers for $95 by contacting Wayne Rhodes ([email protected]).  For IPQ subscription information click here.]

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